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location: North Billerica, Massachusetts
job type: Temporary
salary: $51 - 60 per hour
work hours: 9 to 5
Manage the Investigator Sponsored Trials Program across all product offerings and all processes related to multiple functional areas.
- Independently manages, tracks and monitors the Global Investigator Trials Program (IST) across all marketed products.
- Interfaces with physicians and scientists for study conduct and regulatory compliance for investigator-sponsored trials in a global environment. This includes all facets of the process across multiple functional areas from concept development through to publication and dissemination of findings.
- Ensures IST study files meet GCP requirements, regulatory requirements and accurately reflect the content and status of all IST's.
- Manages the Research Review Committee (RRC) for all pre-clinical and clinical IST protocols.
- Interacts with investigators and site staff as needed to effectively review and implement IST proposals.
- Oversees the IST agreement (contract) process for all IST's, in collaboration with medical, legal and regulatory functions.
- Provides Global Medical Affairs updates to all relevant departments (e.g. R&D, marketing, customer service, business development) as needed
- Ensures adequate understanding of IST study content to be able to fluently interact with staff, external investigators and site staff.
- Develops and maintains knowledge of regulatory and operational aspects of the management of clinical trials in all countries where IST's are located.
- Provides subject matter expertise for SOP development and process improvements for managing IST's. Ensure SOP's accurately reflect best industry practices and benchmarks for IST's, and that compliance with SOP's is documented for all processes.
- Interfaces/ collaborates with Pharmacovigilance, Regulatory Affairs, and Supply Chain functions and external business partners and distributors.
- Ensures accurate reporting on progress, milestone achievement and issues to upper management. Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.
- Makes recommendations for upgrades to program and project content, process, and timelines. Demonstrates technological expertise and understanding of business needs. Evaluates probability and impact of risk, and develop plans to minimize impact on program objectives globally.
- Actively demonstrates and promotes the company values of accountability, quality, efficiency, customer service, collaboration and safety.
- Bachelors degree or equivalent in a scientific or health related field required. Advanced healthcare professional degree (e.g. PharmD, PhD, DO or MD or equivalent) strongly preferred.
- Overall combination of 8+ years scientific and/or clinical experience in industry with minimum 5 years in Investigator-Sponsored Trials activities, in post-marketed products.
- Knowledge of medical imaging field and diagnostics agents preferred.
- Must have excellent relationship management skills.
- Project management training or one or more years of experience.
- Working knowledge of current ethical, GCP and regulatory guidelines.
- Typically requires 1 plus years of related professional industry experience.
- Knowledge/training in Cardiovascular disease and drugs, and imaging agents an advantage.
- A desire to expand upon their knowledge of company pipeline products across multiple imaging platform and disease indications.
- Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form.
- Occasional travel based on educational or business purposes.
skills: SOP, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.